Industry

Medical Devices

Challenges of the industry

The challenge for Medical Devices is to ensure the transition to the new MDR regulations. The transition schedule and the documentary, regulatory and traceability requirements are important to put in place in order to ensure the renewal of their CE marking.

Below you will find how Alispharm can support you in this journey.

We help you in the design of your Medical Devices
• Medical device design
• Product drawings
• Raw material
• Electromedical IEC 60601 & 62304
• Risk analysis ISO 14971
• Usability IEC 62366
• V&V
• Documentary support
• DHF
• Biocompatibility ISO 10993 series

Industrialization

• Industrialization plan
• DMR, DHR, batch records
• Instruction sheets
• FMEA
• Engineering support: CDC, transfer plan
• Line installation
• Go live in production
• Change control piloting

Qualification / Validation

Qualification / Validation of computerized / automated lines and systems (VSI/VSA)
• VMP
• Risk analysis
• QC / IQ / OQ / PQ
• Protocols, test sheets and qualification reports
• Test execution

Validation of special processes
• Cleaning validation ISO 19227
• Gamma, EtO, autoclave sterilization validation ISO 11135, ISO 11137
• Packaging validation ISO 11607

Regulatory Affairs

• Technical file MDR 2017/745
• GSPR
• Risk management ISO 14971
• PMS
• PMCF
• Clinical evaluation MEDDEV 2.7/1 rev 4
• Biocompatibility series ISO 10993
• IFU review, label

Quality Assurance

• Documentary strategy and deployment of ISO 13485
• Non Conformities
• CAPA
• Change Control
• Documentary Control

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